TY - JOUR
T1 - Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus
T2 - Rationale and design of the AleCardio trial
AU - Lincoff, A. Michael
AU - Tardif, Jean Claude
AU - Neal, Bruce
AU - Nicholls, Stephen J.
AU - Rydén, Lars
AU - Schwartz, Gregory G.
AU - Malmberg, Klas
AU - Buse, John B.
AU - Henry, Robert R.
AU - Wedel, Hans
AU - Weichert, Arlette
AU - Cannata, Ruth
AU - Grobbee, Diederick E.
N1 - Funding Information:
The AleCardio trial is funded by the sponsor (F. Hoffmann-La Roche Ltd, Basel, Switzerland). Academic members of the Executive Committee designed the trial in collaboration with the sponsor. The Steering Committee, consisting of the Executive Committee together with the physician National Coordinators from every country involved in the trial, has responsibility for scientific and medical conduct of the study and the presentation and publication of the trial results. A copy of the complete final locked database will be transferred to the Steering Committee for independent statistical analyses of study results for purposes of scientific presentation and publication. The trial is managed by an international partnership of 5 academic research organizations: the Berman Center for Outcomes & Clinical Research (Minneapolis, MN); C5Research, Cleveland Clinic Coordinating Center for Clinical Research (Cleveland, OH); the George Institute for Global Health (Sydney, Australia); Julius Clinical Research, University Medical Center Utrecht (Utrecht, The Netherlands); and the Montreal Heart Institute Coordinating Center (MHICC, Montreal, Canada). These academic research organizations, together with the Roche Study Management and Project Team, coordinate the academic leadership and provide site and data management. An independent DSMB, consisting of physicians and statisticians independent of the trial sponsor and operational leadership, monitors the safety of the study and has access to unblinded data. (See online Appendix ).
PY - 2013/9
Y1 - 2013/9
N2 - Background Peroxisome proliferator-activated receptors (PPARs) regulate transcription of genes involved in glucose uptake, lipid metabolism, and inflammation. Aleglitazar is a potent dual PPAR agonist with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles and biomarkers of cardiovascular risk. The AleCardio trial examines whether the addition of aleglitazar to standard medical therapy reduces the risk of cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and recent acute coronary syndrome. Study Design AleCardio is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. A total of 7,228 patients were randomized to aleglitazar 150 μg or placebo daily in addition to standard medical therapy. The primary efficacy end point is time to the first event of cardiovascular death, myocardial infarction, or stroke. Principal safety end points are hospitalization due to heart failure and changes in renal function. Treatment will continue until 7,000 patients are followed up for at least 2.5 years and 950 primary end point events are adjudicated. Conclusions AleCardio will establish whether the PPAR-α/γ agonist aleglitazar improves cardiovascular outcomes in patients with diabetes and high-risk coronary disease.
AB - Background Peroxisome proliferator-activated receptors (PPARs) regulate transcription of genes involved in glucose uptake, lipid metabolism, and inflammation. Aleglitazar is a potent dual PPAR agonist with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles and biomarkers of cardiovascular risk. The AleCardio trial examines whether the addition of aleglitazar to standard medical therapy reduces the risk of cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and recent acute coronary syndrome. Study Design AleCardio is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. A total of 7,228 patients were randomized to aleglitazar 150 μg or placebo daily in addition to standard medical therapy. The primary efficacy end point is time to the first event of cardiovascular death, myocardial infarction, or stroke. Principal safety end points are hospitalization due to heart failure and changes in renal function. Treatment will continue until 7,000 patients are followed up for at least 2.5 years and 950 primary end point events are adjudicated. Conclusions AleCardio will establish whether the PPAR-α/γ agonist aleglitazar improves cardiovascular outcomes in patients with diabetes and high-risk coronary disease.
UR - http://www.scopus.com/inward/record.url?scp=84883790112&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2013.05.013
DO - 10.1016/j.ahj.2013.05.013
M3 - Article
C2 - 24016490
AN - SCOPUS:84883790112
SN - 0002-8703
VL - 166
SP - 429-434.e1
JO - American Heart Journal
JF - American Heart Journal
IS - 3
ER -